clinical trial · NCT02400281
Study of Crenolanib Combined With Chemotherapy in FLT3-mutated Acute Myeloid Leukemia Patients
Arog Pharmaceuticals, Inc.·phase2·completed·n = 28
Acute Myeloid LeukemiaCrenolanib besylateIdarubicinCytarabineAzacytidineMitoxantroneEtoposideFludarabineG-CSF
brief summary
This is an open label, two-arm, Phase I-II trial, non-randomized. Arm 1: crenolanib with standard chemotherapy (Idarubicin/Cytarabine, MEC;Mitoxantrone/Etoposide/Cytarabine, FLAG-Ida: Fludarabine/Cytarabine/G-CSF/Idarubicin) Arm 2: crenolanib with 5-azacitidine
started
Sep 1, 2015
primary completion
Jul 15, 2020
completion
Jul 15, 2020
last updated
Jul 3, 2024
detailed description
For each arm:
The phase I with dose-limiting toxicity (DLT) determination will use 3+3 design.
Phase II total of 52 patients (26 per arm) will be treated at established phase I dose.
Enrollment to be simultaneous to each arm.
official title
Phase I-II Study of Crenolanib Combined With Standard Salvage Chemotherapy, and Crenolanib Combined With 5-Azacitidine in Acute Myeloid Leukemia Patients With FLT3 Activating Mutations
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol